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A PHASE 2B, RANDOMIZED, PLACEBO-CONTROLLED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN PREGNANT WOMEN 18 THROUGH 49 YEARS OF AGE AND THEIR INFANTS

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A PHASE 2B, RANDOMIZED, PLACEBO-CONTROLLED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN PREGNANT WOMEN 18 THROUGH 49 YEARS OF AGE AND THEIR INFANTS

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 02 Feb 2023

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At a glance

  • Drugs Respiratory syncytial virus vaccine Pfizer (Primary)
  • Indications Respiratory syncytial virus infections
  • Focus Adverse reactions; Proof of concept
  • Sponsors Pfizer

    • Most Recent Events

    • 28 Apr 2022 Interim Results assessing whether RSVpreF vaccine elicited neutralizing antibody responses with efficient transplacental transfer and without evident safety concerns,published in the New England Journal of Medicine
    • 24 Mar 2022 According to a Pfizer media release, based on the data from this study, PF-06928316 or RSVpreF, received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age or older.
    • 02 Mar 2022 According to Pfizer media release, company will publish outcomes from this clinical trial at a future date

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